# K171183: OmniTom

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation
- Decided: Aug 18, 2017 after 116 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944131 (1995). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 4.

## Most influential descendants
- K202526: OmniTom Elite (2020), 5 descendants of its own
- K211711: OmniTom Elite (2022), 4 descendants of its own
- K223447: OmniTom Elite (2023), 3 descendants of its own
- K233767: OmniTom Elite (2024), 2 descendants of its own
- K261125: BodyTom 64 (NL4100); OmniTom Elite (NL5000) (2026), 0 descendants of its own

## Recalls of this device
- Jun 6, 2023 · Class II · Z-2068-2023: 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 devi
- Jul 15, 2020 · Class II · Z-2772-2020: There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient trea

## Indications for use
The NL5000 [OmniTom] system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

Source page: https://510kreport.com/device/K171183
Methodology: https://510kreport.com/methodology